Neoplasm Metastasis, Non-healing Surgical Wound (Disorder), Secondary Malignant Neoplasm of Lymph Node, Skin Neoplasms
Conditions
Keywords
negative pressure wound therapy, lymphadenectomy, wound healing
Brief summary
This study investigates the use of a negative pressure wound therapy device (PICO™, Smith & Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.
Detailed description
Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect \> 40% of patients. A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith & Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.
Interventions
DEVICEPICO™
Negative pressure wound therapy device for closed surgical wounds.
Sponsors
South Eastern Health and Social Care Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
Exclusion criteria
* inability to give informed consent for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound healing | From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery | Determination of wound healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound infection As defined by Comprehensive Complication Index (CCI) | From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery. | As defined by Comprehensive Complication Index (CCI) |
| Lymphoedema (Limb volume measurements) | From date of surgery up to one year post-operatively. | Limb volume measurements at 3, 6, 9 and 12 months |
| Need for further surgical interventions to achieve wound healing | From date of surgery until wound is healed, up to 20 weeks after surgery. | — |
| Scar appearance (POSAS) | From date of surgery up to one year post-operatively. | POSAS at 3,6, 9 and 12 months |
| Patient reported outcomes (qualitative interview) | From date of surgery to six months post-operatively. | Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery. |
Countries
United Kingdom
Contacts
Primary ContactSandra E McAllister, MD
Backup ContactChristopher Hill, MB
Outcome results
None listed